21 CFR § 529.443 - Ciclesonide.

---
identifier: "/us/cfr/t21/s529.443"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 529.443 - Ciclesonide."
title_number: 21
title_name: "Food and Drugs"
section_number: "529.443"
section_name: "Ciclesonide."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "529"
part_name: "CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13881, Mar. 27, 1975, unless otherwise noted."
cfr_part: "529"
---


# 529.443 Ciclesonide.

(a) *Specifications.* A non-pressurized metered dose inhaler and drug cartridge combination containing a solution of 30 milligrams/milliliter of the prodrug ciclesonide. Each actuation releases 343 micrograms (mcg) of ciclesonide.

(b) *Sponsor.* See No. 000010 in § 510.600(c) of this chapter.

(c) *Conditions of use*—(1) *Amount.* Administer an initial dose of 8 actuations (2,744 mcg ciclesonide) twice daily for 5 days, followed by 12 actuations (4,116 mcg ciclesonide) once daily for 5 days.

(2) *Indications for use.* For the management of clinical signs associated with severe equine asthma.

(3) *Limitations.* Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[86 FR 13188, Mar. 8, 2021]